Dolvan Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CAFFEINE, DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, EPHEDRINE HYDROCHLORIDE

Available from:

Norma Chemicals Limited 52 Queen Anne Street, London W1M 9LA, United Kingdom

ATC code:

R06AA52

INN (International Name):

CAFFEINE 30 mg DIPHENHYDRAMINE HYDROCHLORIDE 7.5 mg PARACETAMOL 300 mg EPHEDRINE HYDROCHLORIDE 7.5 mg

Pharmaceutical form:

COATED TABLET

Composition:

CAFFEINE 30 mg DIPHENHYDRAMINE HYDROCHLORIDE 7.5 mg PARACETAMOL 300 mg EPHEDRINE HYDROCHLORIDE 7.5 mg

Prescription type:

OTC

Therapeutic area:

ANTIHISTAMINES FOR SYSTEMIC USE

Authorization status:

Withdrawn

Authorization date:

2006-05-30

Patient Information leaflet

_PLEASE READ THIS LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. IF
YOU_
_HAVE ANY QUESTIONS OR ARE NOT SURE ABOUT ANYTHING, ASK YOUR DOCTOR_
_OR PHARMACIST._
EACH TABLET CONTAINS:
Diphenhydramine HCl BP 7.5 mg,
Ephedrine HCl BP 7.5 mg,
Paracetamol BP 300 mg,
Caffeine BP 30 mg.
_In addition to the above ingredients, the tablets also contain
Dextrin, Corn Starch, _
_Polyvinylpyrolidone, Stearic Acid, Magnesium Stearate, Sucrose,
Kaolin, Talc, _
_Calcium Carbonate, Sodium Benzoate, Opaseal, Gelatine, Acacia,
Beeswax,_
_and colourings E171 and E127._
Dolvan tablets are available in packs of 20.
Diphenhydramine Hydrochloride is an antihistamine. Ephedrine
Hydrochloride is 
a decongestant. Paracetamol is a painkiller and helps reduce the
body 
temperature. Caffeine produces a feeling of wakefulness (counteracting
the 
drowsiness which may be produced by the Diphenhydramine
Hydrochloride).
Dolvan tablets are used for the symptomatic relief in the common cold
and 
influenza, and in nasal congestion associated with allergic stimuli.
You should not use this medicine if you are sensitive to any of the
ingredients or 
you suffer from porphyria. Do not use if you are receiving treatment
with 
monoamine oxidase inhibitors or have received such treatment within
the 
previous two weeks. Do not use if you suffer from any impairment of
the liver or 
kidneys.
You should inform your doctor or pharmacist before taking this
medicine if any 
of the following apply to you: 
#  You are taking any sleep aids or drugs for the relief of anxiety.
#  You are pregnant, trying to become pregnant or are
breast-feeding.
#  You are suffering from prostatic hypertrophy, bladder dysfunction
or 
cardiovascular disorders.
dolvaN tablets
H0015-1
#
norma
SPECIAL WARNINGS
#  Do not take with alcohol.
#  May cause drowsiness. If affected do not drive or operate
machinery.
DOSAGE:
ADULTS AND CHILDREN OVER 12 YEARS: 1 or 2 tablets three times a day.
ELDERLY: One tablet three times a day.
Not recommended for children under 12 years o

Summary of Product characteristics

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1        NAME OF THE MEDICINAL PRODUCT 

Dolvan Tablets 

2        QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each tablet contains: 
Diphenhydramine Hydrochloride BP 7.50mg 
Ephedrine Hydrochloride BP  7.50mg 
Paracetamol BP 300.00mg 
Caffeine BP 30.00mg 

3        PHARMACEUTICAL FORM 

Sugar coated tablets 

4        CLINICAL PARTICULARS 

4.1       THERAPEUTIC INDICATIONS 
Oral  symptomatic  relief  in  the  common  cold  and  influenza  and  in  nasal congestion 
associated with allergic stimuli. 

4.2       POSOLOGY AND METHOD OF ADMINISTRATION 
To be taken by mouth 
Adults and children over 12 years: One or two tablets three times a day 
Elderly: One tablet three times a day 
Children under 12 years: Not recommended 

4.3       CONTRAINDICATIONS 
Hypersensitivity  to  paracetamol  and/or  any  of  the  active  ingredients  and  porphyria.  
Contraindicated    in    persons    under    treatment    with    monoamine  oxidase  inhibitors  and 
within two weeks of stopping such treatment. Known hepatic or renal impairment. 

4.4       SPECIAL WARNINGS AND PRECAUTIONS FOR USE 
Dolvan  may  potentiate  the  effects  of  alcohol  or  other  sedatives,  use  with caution  in  
patients  with  cardiovascular  disorders,  prostatic  enlargement  or bladder dysfunction. 
Care is advised in the administration of Paracetamol to patients  with  severe  renal  or 
severe  hepatic  impairment.  Patients  are  advised not to take any other paracetamol 
containing products concurrently. If symptoms persist the patient should consult their 
doctor. Keep out of the reach of children. 

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